A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin of at least 1500 mg/Day.

Trial Profile

A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin of at least 1500 mg/Day.

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2015

At a glance

  • Drugs Saxagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 18 Oct 2012 Planned number of patients changed from 92 to 220.
    • 31 Aug 2010 Results published in Current Medical Research and Opinion.
    • 31 Aug 2010 Primary endpoint 'Glucose level' has been met according to results published in Current Medical Research and Opinion.
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